K974903 is an FDA 510(k) clearance for the GAS MODULE II, MODEL 0998-00-0143. This device is classified as a Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (Class II - Special Controls, product code CBS).
Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on March 13, 1998, 72 days after receiving the submission on December 31, 1997.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.1620.
| 510(k) Number | K974903 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 1997 |
| Decision Date | March 13, 1998 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Statement |
| Product Code | CBS - Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1620 |